Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Nomax, INC | Saint Louis, MO, United States | Makes it | Problems found, fixed voluntarilyDec 2, 2022 · 6 inspections |
Recalls
- Apr 19, 2024 · Class II · Nomax Inc
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Lots: Lot #s: a) 14904, Exp. 06/30/2024; Lot 14938, Exp. 07/31/2024; b) Lot 14931, Exp. 06/30/2024 - Mar 24, 2015 · Class III · Nomax Inc
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Lots: 1) GloStrips Lot: a) 9031, Exp 12/17; b) 9023, Exp 11/17; 9065, Exp 01/18; 9127 and 9132, Exp 03/18; and 2) Ful-Glo Lot: 9050, Exp 12/18; 9113, Exp 02/19; and 9206, Exp 05/19
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluorescein: every company that makes it
- Form
- strip, ophthalmic
- Strength
- 0.6 mg
- Approval
- UNAPPROVED DRUG OTHER
- On the market since
- Jul 30, 2013
- Package NDCs
51801-003-4051801-003-50- Official label
- DailyMed (National Library of Medicine), updated Dec 23, 2019
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